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Clinical Validation of Embryo Cinematography

This study is currently recruiting participants.
Verified April 2013 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01549262
First received: February 16, 2012
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.


Condition Intervention
Embryo Diagnosis and Selection
 Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)
Device: Observe embryo development

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Ongoing Pregnancy Rate [ Time Frame: confirmed 16-18 weeks after embryo transfer ] [ Designated as safety issue: No ]

Estimated Enrollment: 780
Study Start Date: February 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Incubator Device: Observe embryo development
Observe embryo development in the traditional manner
Experimental: ESD Time-lapse Monitoring system Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)
Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female patients undergoing assisted reproduction with ICSI, first or second cycle
  • 20 to 38 yers old
  • BMI (18-25)
  • No endometriosis,
  • > 6 Metaphse II oocytes
  • Basal FSH < 12 UI
  • AMH > 7pmol/L

Exclusion Criteria:

  • Hydrosalpinx
  • Recurrent pregnancy loss
  • Severe male factor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549262

Contacts
Contact: Marcos Meseguer, PhD (34) 963050900 marcos.meseguer@ivi.es
Contact: Leslie Atkinson, MA (34) 963050900 leslie.atkinson@ivi.es

Locations
Spain
IVI Valencia Recruiting
Valencia, Spain, 46015
Principal Investigator: Marcos Meseguer, PhD            
Sub-Investigator: Irene Rubio, MA            
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Marcos Meseguer, Embryologist IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01549262     History of Changes
Other Study ID Numbers: 1009-C-088-IR
Study First Received: February 16, 2012
Last Updated: April 22, 2013
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013